- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00298636
Dose-Response of Adenosine for Perioperative Pain
August 1, 2006 updated by: Xsira Pharmaceuticals
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Escalating Dose-Response Trial of Intravenous Adenosine for Perioperative Analgesia in Females Undergoing Abdominal Hysterectomy or Myomectomy
Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and represent a non-opiate target for pain management.
Activated spinal A1 receptors inhibit sensory transmission by inhibiting the slow ventral root potential, which is the C-fiber-evoked excitatory response associated with nociception.
Adenosine may inhibit intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory nerve terminals to inhibit the release of substance P and perhaps glutamate.
Although adenosine A3 receptors are not found in the nervous system, adenosine is also known to have anti-inflammatory properties that may contribute to pain relief in the peripheral setting of inflammation.
Study Overview
Study Type
Interventional
Enrollment
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Florida
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Miami, Florida, United States, 33136
- University of Miami/Miller School of Medicine
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Georgia
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Augusta, Georgia, United States, 30912
- Medical College of Georgia
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Winston Salem, North Carolina, United States, 27157
- Wake Forest University/Forsyth Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Texas
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Houston, Texas, United States, 77024
- Memorial Hermann-Memorial City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female gender; age 18 to 65 years;
- American Society of Anesthesiology (ASA) physical classification I to III;
- scheduled for non-emergent abdominal hysterectomy (with or without salpingo-oophorectomy) or myomectomy under general anesthesia;
Exclusion Criteria:
- ASA physical classification of IV or V;
- documented history of cardiovascular disease including coronary artery disease, uncontrolled hypertension, aortic stenosis, congestive heart failure, cardiac arrhythmias or conduction defects greater that first degree atrioventricular (AV) block, sinoatrial (SA) or AV node disease including sick sinus syndrome or symptomatic bradycardia, presence of devices including pacemakers or internal defibrillators, or history of symptoms consistent with any of the aforementioned conditions (e.g., angina, dyspnea on exertion, paroxysmal nocturnal dyspnea);
- history of asthma, bronchospastic lung disease, or hyper-reactive airway disease;
- history of gout;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Dose-response
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Secondary Outcome Measures
Outcome Measure |
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efficacy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tong J Gan, M.D., Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Study Registration Dates
First Submitted
February 28, 2006
First Submitted That Met QC Criteria
February 28, 2006
First Posted (ESTIMATE)
March 2, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
August 2, 2006
Last Update Submitted That Met QC Criteria
August 1, 2006
Last Verified
August 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADO-122
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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